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Afinitor fails Phase III gastric cancer trial

This article was originally published in Scrip

Executive Summary

Novartis's mTOR inhibitor everolimus (marketed as Afinitor) has failed to meet the primary endpoint in a Phase III study in advanced gastric cancer. The company had previously been hoping to file for its approval in this indication this year, having already obtained US and EU approval for its use in kidney cancer and neuroendocrine tumours of pancreatic origin. It had obtained orphan drug status in the gastric indication in both the EU and US last year. Novartis is also hoping to gain FDA and EMA approval of Afinitor in advanced ER+/HER2- breast cancer this year.

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